DRL, Promius Pharma files NDAs with US FDA

By EP News Bureau on April 21, 2015

Dr Reddy’s Laboratories and its subsidiary, Promius Pharma announced the filing of three 505(b)(2) New Drug Applications (NDAs) with the US Food and Drug Administration (US FDA). The three NDAs – DFD-01, DFD-09, and DFN-11, are in support of Dr Reddy’s Proprietary Products group, focused on developing and commercialising therapies in dermatology and neurology.

DFD-01 and DFD-09 are the first dermatology applications submitted to the NDA that have been fully developed leveraging in-house capabilities. DFD-01 is a corticosteroid delivered in a novel non-irritating spray platform, intended for the treatment of patients suffering from psoriasis. DFD-09 is a modified release oral tetracycline intended for the treatment of rosacea. DFN-11 is the first development programme filed in support of a newly created vertical, focused on the US neurology market. DFN-11 is a drug-device combination product intended to treat acute migraine episodes in certain patient populations who are inadequately managed with existing treatment regimens.

Raghav Chari, Executive Vice President of Proprietary Products, Dr Reddy’s and President, Promius Pharma said, “These products potentially represent new, compelling options for specific segments of patients suffering from psoriasis, rosacea and migraine. They are also the first of a large basket of products targeting conditions predominantly treated by the medical dermatologist and neurologist. By focusing exclusively on these two specialty therapeutic areas, we intend to build a leading presence in them over time.” Upon approval, the products will be commercialised by Promius Pharma.

EP Tweet Box

About

Express Pharma, first published as Express Pharma Pulse in 1994, is today India’s leading business fortnightly for the pharmaceutical industry. With the patronage of its readers, Express Pharma has grown to become the No.1 Business News Magazine for the pharmaceutical industry. The editorial contents include: news, views, analysis and interviews, under four main segments: Market (The business of pharmaceuticals), Management (Insight for managing pharma), Research (Expertise for drug development) and Pharma Life (HR issues with a pharma focus). Besides this, we bring out periodic specials like the quarterly Pharma Technology Review, Packaging Special and LABNEXT.